Chief Quality & Compliance Officer – Radiopharma Ops

Jubilant Pharma, LLC

Pennsylvania

Presencial

USD 140.000 - 210.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Jubilant Radiopharmacies is seeking an experienced Director of Quality to lead the Quality Unit supporting PET manufacturing, radiopharmacies, and CDMO operations. This role defines quality strategy, regulatory compliance, inspection readiness, and continuous improvement across multiple locations.

The Director will approve or reject materials and procedures impacting drug quality, partner with senior leadership, operations, pharmacy, R&D, supply chain, regulators, and customers to strengthen

Formación

  • Bachelor's degree in Science or equivalent.
  • 7–10 years in Quality management in pharmaceutical/radiopharmaceutical industries.
  • Deep knowledge of cGMP, 21 CFR 211 & 212, FDA guidelines for radiopharma.
  • Experience leading QA/QC programs, audits, investigations, CAPA.
  • Strong leadership, communication, and cross-functional collaboration.
  • Willingness to travel to multiple facilities as needed.
  • Background check and pre-employment drug test required.
  • Driver's license and ability to operate a vehicle.

Responsabilidades

  • Lead and continuously improve the Quality Management System (QMS).
  • Provide guidance on cGMP requirements and regulatory standards (FDA, BOP, ISO/ICH).
  • Lead QA/QC teams across PET manufacturing, radiopharmacies, and CDMO operations.
  • Maintain independent Quality Unit oversight of materials, records, labs, and third parties.
  • Oversee audits, inspections, CAPA, investigations, and risk management programs.
  • Develop and present quality metrics, trends, and risk assessments to leadership.
  • Represent Jubilant Radiopharmacies to federal and state regulators.
  • Mentor and develop Quality staff across multiple locations.

Conocimientos

Quality leadership
cGMP knowledge
Regulatory inspections
Cross-functional collaboration
Audits
CAPA

Educación

Bachelor's degree (Science)

Descripción del empleo

Jubilant Radiopharmacies is seeking an experienced Director of Quality to lead the Quality Unit supporting PET manufacturing, radiopharmacies, and CDMO operations. This role defines quality strategy, regulatory compliance, inspection readiness, and continuous improvement across multiple locations.

The Director will approve or reject materials and procedures impacting drug quality, partner with senior leadership, operations, pharmacy, R&D, supply chain, regulators, and customers to strengthen

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